- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077008
Mode of Drainage Of Bilaterally Obstructed Kidneys
Mode of Drainage Of Bilaterally Obstructed Kidneys Due to Benign or Malignant Causes: A Prospective Comparative Study
Bilaterally obstructed kidneys could be caused by benign or malignant causes it could lead to renal failure which can be avoided by urgent drainage either by PCN or DJ , The aim is to determine whether unilateral or bilateral drainage make a difference in improvement of renal function of bilaterally obstructed kidneys and whether that improvement relays on the cause of the obstruction.
The investigators will do that by doing a prospective comparative study on patients presented to our department by bilaterally obstructed kidneys , by either benign or malignant causes , with high serum chemistry. Intervention to this cases will be done by inserting JJ or PCN either unilateral or bilateral depending upon lab workups , our staff decision and patients fittness and agreement .
Study Overview
Status
Conditions
Detailed Description
Kidney obstruction means obstruction of urinary flow with back pressure on the kidney, which may be unilateral or bilateral, may have many causes either benign e.g; urolithiasis, retroperitoneal fibrosis, renal papillary necrosis or malignant e.g; urinary tract tumors as bladder cancer and prostate cancer, or Extrinsic tumor as cervical cancer(5) , lymphoma or other pelvic tumors When kidney obstruction occurs bilaterally this raises serum chemistry and may lead to post-renal AKI which represents about (1-10%) of all causes of AKI. Post-renal AKI is an emergency case that requires an urgent and minimally invasive procedure to drain the urine either by PCN or ureteric stents.
There has been always a debate about which one is better to drain the obstructed kidneys percutaneous nephrostomy or ureteric stents and which is better in improvement of renal function and with less effect on life style . Also the mode of drainage of the obstructed kidneys, bilateral or unilateral, also has been a point of debate. Unless bilateral renal obstruction is due to benign or treatable malignant cause, unilateral nephrostomy is always the rule according to some authors . some authors, reported better improvement in renal function with bilateral PCN with pelvic tumors The investigators will do prospective comparative study for studying mode and laterality of drainage in benign and malignant causes in bilaterally obstructed kidneys .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients ( >18 yrs ) with bilateral obstructed kidneys
- Bilateral obstructed kidneys due to benign causes
- Bilateral obstructed kidneys due to malignant causes
- Bilateral obstructed kidneys with high serum creatinine
Exclusion Criteria:
- Age < 18 yrs
- Bilateral obstructed kidneys with normal serum creatinine
- patients with chronic kidney disease
- Vesicoureteric reflux
- Severe comorbidity preventing intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Bilaterally Obstructed Kidneys by benign cause
|
drainage of obsructed kidneys by PCN or jj
drainage of obsructed kidneys by PCN or jj
|
Other: Bilaterally Obstructed Kidneys by malignant cause
|
drainage of obsructed kidneys by PCN or jj
drainage of obsructed kidneys by PCN or jj
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
when the serum creatinine comes to normal after drainage of bilaterally obstructed kidneys either on one side or 2 sides
Time Frame: 2 years
|
The investigators will measure seum creatinine of patients with bilaterally obstructed kidneys and raised serum chemistry who are in urgent need for intervention .
After intervention , either by PCn or ureteric stents , serum chemistry will be measured in those patient again in fixed times e.g; after 6 hrs , 1 day , 3 days , 1 week , 2 weeks .
after collecting and processing the data we will come to a conclusion either bilateral drainage of patients with bilaterally obstructed kidneys due to benign cause is faster to return serum chemistry to normal than unilateral drainage.
The same will be applied to patients of bilaterally obstructed kidneys due to malignant cause .
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Drainage of BOK In B or M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Nephropathy
-
Josep M CruzadoWyeth is now a wholly owned subsidiary of PfizerCompletedGlomerulonephritis, IGA | IGA Nephropathy | Nephropathy, IGASpain
-
Visterra, Inc.CompletedImmunoglobulin A Nephropathy | IgA Nephropathy | IgAN - IgA NephropathyUnited States
-
National Institute of Allergy and Infectious Diseases...Terminated
-
Russian Academy of Medical SciencesRussian Scientific Center of SurgeryCompletedAcute Graft Rejection | Chronic Allograft Nephropathy | Polyomavirus-related Transplant NephropathyRussian Federation
-
Hospital Universitario 12 de OctubreInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz; Fundación... and other collaboratorsCompletedMEMBRANOUS NEPHROPATHYSpain
-
Rigel PharmaceuticalsWithdrawn
-
Rigel PharmaceuticalsCompletedIGA NephropathyUnited States, United Kingdom, Hong Kong, Taiwan, Austria, Germany
-
Uppsala University HospitalHaukeland University Hospital; University Hospital, Linkoeping; Smerud Medical...UnknownIGA NephropathyNorway, Sweden
-
Calliditas Therapeutics ABArchimedes Development LtdCompletedIGA NephropathySweden
-
Excel Diagnostics and Nuclear Oncology CenterRadiomedix, Inc.CompletedRadiation Nephropathy